CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Digital Health Technologies - Therapeutic Applications

This policy governs coverage determinations for FDA-marketed therapeutic digital health applications intended for treatment of panic disorder, PTSD, and nightmare disorder for BCBSRI members; it applies to Medicare Advantage and Commercial products as specified.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyDigital Health Technologies - Therapeutic Applications

Policy CodePolicy N/A

Change TypeTechnical update (no material coverage changes)

Effective DateOct 1, 2023

Next Review DateN/A

Key ActionVerify member benefits and applicable benefit booklet, Evidence of Coverage, or Subscriber Agreement before providing or billing for these technologies.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2Named technologies

A9291Not covered / NMN code

3SaMD criteria

InsufficientEvidence conclusion

Coverage Determinations

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Named digital therapeutics coverage determinations

Policy determinations for Freespira and NightWare:

Freespira - Medicare Advantage: Freespira is not covered for all indications including treatment of panic disorder and/or post-traumatic stress disorder

Evidence insufficient to determine effect on health outcomes

Freespira - Commercial: Freespira is not medically necessary for all indications including treatment of panic disorder and/or post-traumatic stress disorder

Evidence insufficient to determine effect on health outcomes

NightWare - Medicare Advantage: NightWare is not covered for all indications including treatment of nightmare disorder or nightmares from posttraumatic stress disorder

Single pivotal trial did not meet primary endpoint; evidence insufficient

NightWare - Commercial: NightWare is not medically necessary for all indications including treatment of nightmare disorder or nightmares from posttraumatic stress disorder

Evidence insufficient; benefit uncertain

Benefits may vary between groups and contracts. Refer to the member’s specific Benefit Booklet, Evidence of Coverage, or Subscriber Agreement to determine whether Freespira or NightWare are covered, not covered, or considered not medically necessary for that contract.

For Commercial Products, both Freespira and NightWare are listed as not medically necessary because the evidence is insufficient to determine their effects on health outcomes.

Provider Requirements and Billing Guidance

Prior Authorization

Prior authorization: Not applicable.

Step Therapy

Step therapy / Benefit variability

Benefits may vary by contract. There are no specific step therapy requirements listed in this policy; coverage depends on the member's contract-specific benefit design. Providers must verify coverage, limitations, and any applicable step therapy or other utilization management rules in the member's Benefit Booklet, Evidence of Coverage, or Subscriber Agreement before rendering or billing services.

Coverage depends on contract-specific benefits
No step therapy requirements specified in this policy

Note

Verify member benefits

Verify member benefits and contract terms prior to providing services. Benefits, coverage determinations, and applicability of medical necessity or not-covered rules vary by group and contract; providers must confirm the member's applicable Benefit Booklet, Evidence of Coverage, or Subscriber Agreement.

Providers must verify member-specific coverage before treatment or billing

Denial Risk

Billing denial risk for A9291

The HCPCS code A9291 is listed as not covered / not medically necessary for Medicare Advantage and Commercial Products. Billing for A9291 may be denied; do not bill this code for covered services under these products.

A9291 — Prescription digital cognitive and/or behavioral therapy, FDA cleared, per course of treatment: Not covered / Not medically necessary

Background and Scope

Digital therapeutic applications, often described as Software as a Medical Device (SaMD), are software intended for medical purposes that operate without being part of a hardware medical device. This policy applies to FDA-marketed therapeutic SaMD that are prescribed by a provider and addresses technologies intended to treat conditions such as panic disorder, post-traumatic stress disorder, and nightmare disorder.

Key Definitions

SaMD — Software as a Medical Device (SaMD) definition and related points

DefinitionSoftware as a Medical Device (SaMD): software intended to be used for one or more medical purposes that performs those purposes without being part of a hardware medical device.

Scope requirement 1Must meet the SaMD definition (intended for medical purpose and not part of a hardware medical device or merely storing/transmitting medical information).

Scope requirement 2Must have received U.S. FDA marketing clearance or approval (De Novo, 510(k), or PMA).

Scope requirement 3Must be prescribed by a healthcare provider to fall within this policy's scope.

Examples / contrastSaMD contrasts with software integral to a device or software used only for manufacture/maintenance; previously called 'standalone software' or 'medical device software'.

Digital Therapeutic Modalities

Digital therapeutic (Freespira, NightWare)

Freespira modality: Breath-to-breath ETCO2 biofeedback device and training protocol over 4 weeks targeting respiratory control in panic disorder and PTSD4-week program

Evidence from single-arm studies with high loss to follow-up; insufficient evidence

NightWare modality: Wearable-based algorithm using Apple Watch/iPhone to detect nightmares and deliver vibration to disrupt nightmares during sleep as adjunct to usual careused during sleep

Single pivotal trial did not meet primary endpoint; insufficient evidence